NCT04995887

RUBY Post-Market Registry on the Jada® System

RUBY: Treating Abnormal Postpartum Uterine Bleeding or Postpartum Hemorrhage With the Jada® System - A Post-Market Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 809 (actual)
• Sponsor: Alydia Health · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The RUBY Study is a multicenter, observational, post-market registry designed to collect observational data on patients treated with the Jada System in the post-market setting.

Detailed description

The purpose of this registry is to collect observational data on patients treated with the Jada System in the post-market setting. Data collection will include observations of effectiveness and safety of the device. Additional outcome data related to resource utilization will also be included.

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
DEVICE	Jada® System	The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. It is a teardrop-shaped, soft silicone ring that is placed into the uterus, where gentle suction is applied to cause the uterus to contract and shrink in size, compressing the blood vessels so the bleeding stops.

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-03-31
• Completion: 2022-04-30
• First posted: 2021-08-09
• Last updated: 2022-08-22

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated device study